F.D.A. Panel Backs Taxol as Cancer Drug

Published: November 17, 1992

ROCKVILLE, Md., Nov. 16—
A Food and Drug Administration panel recommended today that taxol, an anti-cancer drug made from the rare Pacific Northwest yew tree, be approved for treatment of ovarian cancer.

The committee recommended that the drug, made by Bristol-Myers Squibb Co., be approved for patients who fail to respond to conventional chemotherapy.

Recommendations by advisory panels are not binding but the F.D.A. usually accepts them. Analysts said they expected the agency to act by the end of the year or early in 1993.

A natural compound derived from the bark of the Pacific yew, taxol has been called the most promising cancer-fighting discovery in 15 years. It prevents cancer cells from dividing and multiplying and has also shown promise in treating breast and lung cancer.

Bristol-Myers stands to profit handsomely from eventual sales of the drug, but controversy surrounds taxol because yew trees grow in protected national forests and each tree yields only a small amount of the drug. Researchers are ways to mass produce it in the laboratory.

Ovarian cancer ranks among the leading causes of cancer death in women, killing about 12,500 a year. Bristol-Myers developed Taxol in conjunction with the National Cancer Institute with the help of public funds. The cancer institute has distributed the drug free to many women who have not responded to standard chemotherapy.

The panel later also recommended the use of Tamoxifen for treating advanced metastatic male breast cancer. The drug, manufactured by the U.S. division of Imperial Chemical Industries, is already widely used to treat breast cancer in women.